Regulatory Affairs Specialist Job At Cepheid Danaher Bengaluru
Cepheid, a Danaher operating company, is hiring a Regulatory Affairs Specialist in Bengaluru East. This Regulatory Affairs Job role supports global on-market sustainment activities by managing regulatory documentation, global change notifications, and post-market submissions for IVD and medical device products, ensuring continuous global compliance. Graduates seeking Pharmacy Jobs and want to start their career in Pharmacy Careers can apply now.
Job Details
- Job Title: Regulatory Affairs Specialist
- Location: Bengaluru East, Karnataka, India
About the Company
Cepheid, part of Danaher Corporation, is a global leader in molecular diagnostics, delivering fast, accurate diagnostic systems and tests that improve patient outcomes worldwide. Guided by the Danaher Business System, Cepheid fosters innovation, continuous improvement, and global regulatory excellence.
Educational Requirements
- Master’s degree with 2+ years of relevant regulatory experience
OR - Bachelor’s degree with 5+ years of experience in Regulatory Affairs, Quality, or Compliance within a medical device or IVD environment
Key Responsibilities
- Create, update, and maintain regulatory documentation and controlled files in compliance with global IVD and medical device regulations.
- Prepare documentation packages for global change registrations and on-market product updates.
- Compile regulatory submission materials for renewals, annual registrations, and regional filings.
- Identify, track, and apply local, regional, and global regulatory requirements using validated regulatory intelligence sources.
- Perform regulatory impact assessments and document applicability and required actions.
- Support planning activities, internal audits, and regulatory inspections.
- Stay current with evolving regulatory policies and standards.
- Provide regulatory training and guidance to cross-functional teams.
- Support post-market regulatory compliance activities.
Skills Required
- Strong understanding of medical device and IVD regulatory frameworks.
- Ability to interpret and apply complex global regulatory requirements.
- Experience with regulatory documentation and submission compilation.
- Knowledge of regulatory intelligence tools and databases.
- Strong analytical, organizational, and problem-solving skills.
- Effective communication and cross-functional collaboration abilities.
Preferred Qualifications
- Knowledge of Global IVD regulations and CE-IVDR.
- Experience with systems such as SAP, Agile, TrackWise, or similar databases.
- Background in Quality Control, Quality Systems, Compliance, or Assurance.
Why This Job Role?
This Regulatory Affairs Job role offers global regulatory exposure in a high-impact molecular diagnostics organization, with opportunities to work on post-market sustainment, global submissions, and regulatory strategy within the Danaher ecosystem. Graduates seeking Pharmacy Jobs and want to start their career in Pharmacy Careers can apply now.
